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Article Type: Clinical Article

Accepted Article Subheading: Gynecology

CLINICAL ARTICLE

Misoprostol use for second-trimester termination of pregnancy among women

with one or more previous cesarean deliveries

Martin Cuellar Torriente 1, Wilhelm J. Steinberg 1,*, Gina Joubert 2

1
Department of Family Medicine, Faculty of Health Sciences, University of the Free

State, Bloemfontein, South Africa


2
Department of Biostatistics, Faculty of Health Sciences, University of the Free

State, Bloemfontein, South Africa

* Correspondence

Wilhelm J. Steinberg, Department of Family Medicine (G19), Faculty of Health

Sciences, University of the Free State, PO Box 339, Bloemfontein 9330, South

Africa.

Email: steinbergwj@ufs.ac.za

Keywords: Misoprostol; Previous cesarean delivery; Safety; Second-trimester

termination of pregnancy; South Africa; Termination of pregnancy

This article has been accepted for publication and undergone full peer review but has not
been through the copyediting, typesetting, pagination and proofreading process, which may
lead to differences between this version and the Version of Record. Please cite this article as
doi: 10.1002/ijgo.12168

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Synopsis: The local misoprostol regimen used for second-trimester termination of
Accepted Article pregnancy was found to be safe among patients with previous cesarean deliveries,

but showed reduced efficacy.

Abstract

Objective: To establish the safety and efficacy of misoprostol for second-trimester

termination of pregnancy among women with one or more previous cesarean

deliveries.

Methods: In a retrospective study, data were reviewed from women attending a

reproductive health clinic in Bloemfontein, South Africa, for second-trimester

termination between 2010 and 2013. The study group, comprising women with one

or more previous cesareans, was compared with a control group, comprising women

with no previous cesarean or uterine scarring. Procedure-specific information was

compared, including misoprostol use, termination duration, need for other methods

(e.g. oxytocin), placenta delivery, termination outcome, and bleeding.

Results: The study group comprised 268 women: 231 (86.2%) with one and 37

(13.8%) with two previous cesareans. The control group comprised 266 women.

Incomplete abortion was recorded in 223 (85.4%) of 261 women in the study group

and 213 (80.4%) of 265 in the control group. The number of women with retained

placenta was higher in the study than in the control group (158/261 [60.5%] vs

146/265 [55.1%]; P<0.001). Severe bleeding was observed only in the control group

(7/266 [2.6%]). No uterine rupture was observed.

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Conclusion: Misoprostol was safe for second-trimester termination among women
Accepted Article with previous cesareans; however, the efficacy of the local regimen was reduced

owing to high placental retention.

1 INTRODUCTION

In the past decade, cesarean deliveries have been increasing worldwide [14]. As a

result, the number of women seeking termination of pregnancy with one or more

uterine scars is also increasing [57]. The overall incidence of pregnancy-related

uterine rupture is 0.07%; however, this can increase to 0.5% among women who

have had a previous cesarean [8]. Furthermore, women with an unscarred uterus

living in low-income countries have a higher incidence of uterine rupture (0.11%) as

compared with those living in high-income countries (0.012%) [8].

Medical abortion offers an alternative to surgical abortion. Labor induction is used for

5% of second-trimester terminations in the USA, 25% in England, and nearly all

second-trimester terminations in Sweden and Finland [9]. Misoprostol is widely used

for termination of pregnancy because of its effectiveness. The drug is also stable at

ambient temperature and less costly than other methods [1012]. Although

misoprostol is considered safe for second-trimester terminations, the safety of its use

for women with a uterine scar remains uncertain [2,7,1113].

The Reproductive Health Clinic at National District Hospital, Bloemfontein, South

Africa, has been established for more than 15 years and provides terminations under

the Choice of Termination of Pregnancy Act 92 of 1996 [1416]. On an annual basis,

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the clinic performs 30004000 terminations. When the clinic started its service in the
Accepted Article late 1990s, pregnancy termination was not allowed for pregnancies beyond 12

weeks if a cesarean had been performed in the previous 24 months owing to the

possibility of complications. In 2009, this time interval was reduced to 18 months for

pregnancies between 13 and 16 gestational weeks. The safety of performing a trial

of scar (i.e. vaginal birth after cesarean) at term depends on various factors,

including an interval of at least 18 months between the previous cesarean and the

current delivery [8,13,17].

The aim of the present study was to establish the safety and efficacy of the local

regimen of misoprostol for second-trimester terminations among women with one or

more previous cesarean deliveries, as compared with women with no previous

cesarean or other uterine operations.

2 MATERIALS AND METHODS

In a retrospective analytical study, data were reviewed from women attending the

Reproductive Health Clinic, National District Hospital, Bloemfontein, South Africa, for

a second-trimester termination between January 1, 2010, and December 31, 2013.

The study was approved by the Ethics Committee of the Faculty of Health Sciences,

University of the Free State, South Africa. Written approval from the hospital

authorities of National District Hospital was obtained to access patient files. All

information was handled confidentially. Individual informed consent was not deemed

necessary because the study involved a retrospective record audit.

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The study group comprised women with a history of one or more previous cesareans
Accepted Article who underwent a second-trimester termination (i.e. at 1320 weeks). For each

woman included in the study group, the next patient in the register who underwent a

second-trimester termination but had no history of previous cesarean delivery or

other operations that might cause uterine scarring was included in the control group.

None of the patients had a contraindication for prostaglandin use, or any other

contraindications to undergo termination of pregnancy.

The following misoprostol protocol is used at the Reproductive Health Clinic for

pregnancies between 13 and 20 weeks: 800 g misoprostol vaginally as a loading

dose, followed by 200 g orally every 2 hours for three doses starting 3 hours after

the vaginal dose, up to a maximum of 1400 g (regimen 1). The waiting period is

24 hours after the first dose of misoprostol. If the abortion does not occur during this

time, a second regimen is administered that consists of 400 g misoprostol vaginally

every 4 hours up to a maximum of 1200 g (regimen 2). When the patient

experiences sufficient contractions or starts to bleed, or the products are expelled,

no further misoprostol doses are given. If, after the second regimen, a further 24

hours have lapsed and the abortion has not occurred, the patient is given an

oxytocin infusion (20 IU in 1 L Ringers lactate) over 16 hours at a rate of 125 mL/h. If

the oxytocin infusion fails, a formal dilatation and evacuation (D&E) is done in theater

via a paracervical lignocaine block, supplemented with an intramuscular injection of

diclofenac sodium (75 mg). All women are assessed after the abortion to decide

whether manual vacuum aspiration (MVA) is necessary.

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Data from patient files were recorded on a self-compiled data sheet and included
Accepted Article age, obstetric history (gravidity and parity), number of previous cesareans, months

since the last cesarean, and length of pregnancy in weeks. The period of

amenorrhea, when known, was used to determine pregnancy length and was

confirmed by ultrasonography. When the period of amenorrhea was unknown, the

ultrasonography result was used.

Procedure-specific information included misoprostol use (regimen 1, or regimens 1

and 2), duration of termination, need for other methods (oxytocin, D&E, or MVA),

placenta delivery, incomplete or complete termination, and presence of severe

bleeding. The duration of the termination was measured from the time that the

treatment protocol was initiated to the expulsion of products. A successful

termination was considered as the complete or partial expulsion of the uterine

content. The abortion was considered incomplete if the placenta was retained for

more than 1 hour.

Data were analyzed using SAS version 9.3 (SAS Institute, Cary, NC, USA).

Categorical variables were summarized as number (percentage); continuous

variables were summarized as median (interquartile range [IQR]) because of skew

distributions. Subgroups were compared by MannWhitney U test for continuous

variables, and 2 or Fisher exact test for categorical variables depending on the cell

size. Logistic regression adjusting for demographic variables differing significantly

between the study and control groups was performed for the main outcomes. P<0.05

was considered statistically significant.

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Accepted Article 3 RESULTS

The study group comprised 268 women with one or more previous cesareans, and

the control group comprised 266 women without a uterine scar. Because of an

administrative error, one patient was erroneously initially included as a control, but

had actually had a previous cesarean delivery and as such was transferred to the

study group. Of the women in the study group, 231 (86.2%) women had one

previous cesarean, and 37 (13.8%) had two previous cesareans.

Women in the study group were older than those in the control group (Table 1). The

median number of pregnancies (gravidity) and births (parity) were the same in both

groups, but the 25th percentiles differed (both P<0.001) (Table 1). There was a

difference of 1 week in median pregnancy length between the study group and the

control group (P<0.001) (Table 1). The total number of previous abortions was

slightly higher in the study group than in the control group, although the difference

was not significant (Table 1). For the study group, the median duration between the

last cesarean and the current termination was 48 months.

Women with two previous cesareans were significantly older and had significantly

higher parity and gravidity than those who had one previous cesarean (P<0.001)

(Table 1). The median duration since the last cesarean for women with two

procedures was also significantly longer than that for women with one cesarean

(P=0.0409) (Table 1). The women in both subgroups were significantly older and had

higher parity and gravidity as compared with the control group (P<0.001 for all

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comparisons). The pregnancy length for women with one cesarean was significantly
Accepted Article shorter than that of the control group (P<0.001).

The median time from induction to expulsion was 9 hours in both the study and the

control groups. In both groups, the highest percentages of terminations were

completed between 7 and 12 hours, followed by 6 hours or less (Table 2). Most of

the terminations took less than 24 hours.

The rate of termination success by using regimen 1 only was significantly higher in

the study group than in the control group (P=0.0481) (Table 3). Few women in either

group needed oxytocin or D&E. Most women in the study and control groups

required an MVA. In both groups, at least 80% of the abortions were incomplete

(Table 3). The number of women with retained placenta was significantly higher in

the study group than in the control group (P<0.001) (Table 3). Severe bleeding was

observed only in the control group. There was no need for blood transfusion in either

group, and no women experienced uterine rupture.

In a logistic regression model adjusted for patient age, parity, gravidity, and length of

pregnancy, the significance of factors was similar to those observed in the univariate

comparison of the study and control groups: regimens 1 and 2, P=0.0602; oxytocin

use, P=0.1764; D&E, P=0.1953; MVA needed, P=0.1827; retained placenta,

P=0.0015; and incomplete abortion, P=0.1418. The logistic model could not be fitted

for severe bleeding owing to the small sample size.

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Women with one previous cesarean had a higher incidence of retained placenta
Accepted Article (P=0.0015) and a lower incidence of bleeding (P=0.0166) as compared with the

control group. Women with two cesareans had a higher incidence of retained

placenta (P=0.0084) and a lower incidence of incomplete abortion (P=0.0441) as

compared with the control group. No significant differences regarding outcomes were

found between women with one and those with two cesareans (Table 3).

4 DISCUSSION

The present study found a significant difference between the study group and the

control group in terms of age at time of termination, gravidity, and parity. The control

group was younger, and a significantly higher percentage of women were

primigravidas. The latter variable, however, did not influence the outcomes. The

median duration between induction and expulsion was 9 hours in both groups. A

high percentage of women aborted in the first 12 hours after treatment initiation. The

success rate in the first 24 hours was 93.3% in the study group and 88.3% in the

control group. Previously reported success rates using misoprostol range from 71%

to 100% for women with an intact uterus [5,6,10,12,18], and from 74% to 90% for

women with a previous cesarean [2,46,18]. In the present study, all women in both

the study group and the control group eventually expelled the fetus using regimen 1,

regimen 2, oxytocin, and/or D&E.

Women with a scarred uterus are presenting for second-trimester pregnancy

termination on a more regular basis [57]. Studies on the use of misoprostol alone

among women with previous cesareans are limited, and a lack of randomized trials

makes it difficult to draw conclusions [5,6]. Despite the evidence that misoprostol is

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effective, its safety for use among women with one or more previous cesareans
Accepted Article remains uncertain [1,2,11].

The dose, route, and interval of misoprostol administration vary widely, from three to

six doses of 200800 g (up to 1800 g) at intervals ranging from 3 to 12 hours,

among women with and without a history of previous cesareans [1,12,19,20]. In

some studies, the misoprostol regimen was supplemented with an additional rectal

dose when products of conception were retained [12]; in others, oxytocin was

administered after fetal expulsion to complete the abortion, with no increase in

complications [6]. The misoprostol regimen administered at the study clinic uses

lower doses than reported in other regimens [2,6,11,12].

In the present study, the median duration of termination was longer for women with

two previous cesareans than for those with one procedure. The median induction-to-

expulsion time was shorter than that reported by other authors [2,4,11,18], who

noted durations ranging from 14.5 to 42.6 hours using different regimens. In the

present study, the high-loading vaginal dose used in regimen 1 is likely to increase

the uterine response, leading to stronger contractions faster as compared with lower

doses.

The plasma concentration of misoprostol after vaginal administration increases

gradually and reaches maximum levels after 7080 minutes, remaining high for at

least 4 hours [20]. After oral administration, the plasma level peaks at approximately

30 minutes, and declines rapidly with a half-life of 2040 minutes [20]. The vaginal

route is considered more effective than the oral route [18]. It has been found that a

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low dose of misoprostol could be ineffective for termination of pregnancy in the mid-
Accepted Article trimester, resulting in an extended induction-to-expulsion interval that ultimately

requires higher total doses of misoprostol [2,21].

Overall, there was a high rate of placental retention, with a higher rate in the study

group than in the control group. Dickinson [5] reviewed data from 720 women who

underwent second-trimester abortions using misoprostol in various dose regimens

(200600 g). Of these women, 101 (14%) had at least one previous cesarean.

Similar to the present study, Dickinson [5] found a higher rate of placental retention

among women with a previous cesarean (41.6%) than among women with no

previous cesarean (34.4%). He proposed that the reason for the overall high rate of

retention might be low uterine contractility, because misoprostol was stopped after

fetal expulsion and a high proportion of women did not receive the complete dosage

(1400 g) of the first regimen. In the present study, retained placenta occurred more

often among patients with two previous cesareans than among those with one

previous procedure. Fibrosis resulting from previous operations might diminish

uterine contractility, causing retention of placenta.

The expulsion of uterine content was considered incomplete in 85.4% of the study

group and 80.4% of the control group in the present study. These values are higher

than those reported by Latif et al. [19], who found that surgical evacuation was

needed in 68.9% of terminations, although they used oxytocin infusion after fetal

expulsion. In the present study, the incidence of surgical evacuation was higher

among women with two previous cesareans than among those with one cesarean,

which is consistent with the above hypothesis on diminished uterine contractility.

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Accepted Article In the present study, the only medical complication observed was severe bleeding,

which occurred in 2.6% of women in the control group and none in the study group.

No uterine rupture was reported in either group. Similarly, Dickinson [5] reported no

uterine rupture in his review of women with or without previous cesarean deliveries.

In a study of 138 women, 31 of whom had three or more previous cesareans, Fawzy

and Abdel-Hady [4] used 200-g doses of misoprostol vaginally every 6 hours in the

first 24 hours, followed by 400-g doses every 6 hours. They observed one

occurrence of uterine rupture in the study group during hysterotomy. Gle et al. [2]

used 400-g doses of vaginal misoprostol every 4 hours in a study of 60 women with

one cesarean, 26 with two or more cesareans, and 193 control women. They

reported uterine rupture for three women, all of whom had either two or three

previous cesareans. Uterine rupture, hemorrhage, and hysterotomy/hysterectomy,

although rare, remain potential complications of any method used in second-

trimester termination [4,10]. The risk of uterine rupture is reported to increase when

oxytocin is used in combination with prostaglandins [12,19,20].

The present study has some limitations. The data were gathered via a retrospective

record review with no prospective information. It was assumed that the local

regimens of misoprostol were administered as recorded, but it is possible that some

women received additional medication, although this is unlikely. Additionally, uterine

scar complications might have been missed if clinical signs did not manifest in the

patients. The study excluded women who had been lost to follow-up. However, if no

complications were noted, it remains theoretically possible that they might have been

missed.

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Accepted Article In conclusion, misoprostol alone seems safe for second-trimester pregnancy

termination among women with one or more previous cesarean deliveries. As

compared with control women, however, the local misoprostol regimen used was not

as efficient for women with previous cesareans, because more of these women had

placental retention. Larger studies are needed to improve statistical power. Although

misoprostol seems to be safe, continual surveillance of complications must be

maintained.

Author contributions

MCT conceived the study, developed the protocol, performed data collection, and

drafted the manuscript. WJS assisted with protocol development, analysis and

interpretation of data, and manuscript revision. GJ assisted with study planning,

performed data analysis, and helped with data interpretation and manuscript

revision.

Acknowledgments

We thank Ms. T. Mulder, medical editor (School of Medicine, University of the Free

State), for technical and editorial preparation of the manuscript.

Conflicts of interest

The authors have no conflicts of interest.

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a
Table 1 Demographic and obstetric characteristics.
Characteristic All women (n=534) Study group (n=268)
Study Control group P One Two P
group (n=266) value cesarean cesareans value
(n=268) (n=231) (n=37)
Age, y 27 (24 24 (2030) <0.001 26 (2431) 30 (2733) 0.001
32)
Gravidity 2 (23) 2 (13) <0.001 2 (23) 3 (33) <0.001
Parity 1 (12) 1 (02) <0.001 1 (13) 2 (22) <0.001
Length of pregnancy, 14 (13 15 (1316) <0.001 14 (1316) 14 (1316) 0.9503
wk 16)
Duration since last 48 (33 46 (3176) 53 (4199) 0.0409
cesarean, mo 81)
Previous terminations 15 (5.6) 11 (4.1) 0.4326 13 (5.6) 2 (5.4) >0.99
a
Values are given as median (interquartile range) or number (percentage), unless indicated
otherwise.

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a
Table 2 Time from initiation of misoprostol treatment until expulsion.
Time, h All women (n=534) Study group (n=268)
Accepted Article Study group Control group One cesarean Two cesareans (n=37)
(n=268) (n=266) (n=231)
6 55 (20.5) 61 (22.9) 47 (20.3) 8 (21.6)
712 125 (46.6) 133 (50.0) 109 (47.2) 16 (43.2)
1318 30 (11.2) 31 (11.7) 27 (11.7) 3 (8.1)
1924 19 (7.1) 11 (4.1) 14 (6.1) 5 (13.5)
>24 39 (14.6) 30 (11.3) 34 (14.7) 5 (13.5)
Overall 9 (715) 9 (713) 9 (715) 10 (719)
a
Values are given as number (percentage) or median (interquartile range).

Table 3 Outcomes.a

Outcome All women (n=534) Study group (n=268)


Study group Control P One cesarean Two cesareans P
(n=268) group value (n=231) (n=37) value
(n=266)
Induction method
needed
Regimen 0.0481 >0.99
1b 250 (93.3) 235 (88.3) 215 (93.1) 35 (94.6)
1 and 2 b 18 (6.7) 31 (11.7) 16 (6.9) 2 (5.4)
Oxytocin use 12 (4.5) 6 (2.3) 0.1549 9 (3.9) 3 (8.1) 0.2208
Dilatation and 6 (2.2) 2 (0.8) 0.2854 4 (1.9) 2 (5.4) 0.1945
evacuation
Complications c
Manual vacuum 230/263 219/265 (82.6) 0.1212 196/227 (86.3) 34/36 (94.4) 0.2761
aspiration needed (87.5)
Retained placenta 158/261 146/265 (55.1) <0.001 134/226 (59.3) 24/35 (68.6) 0.2960
(60.5)
Incomplete abortion 223/261 213/265 (80.4) 0.1231 190/226 (84.1) 33/35 (94.3) 0.1108
(85.4)
Severe bleeding 0 7 (2.6) 0.0073 0 0
a
Values are given as number (percentage) or number/total number (percentage), unless indicated
otherwise.
b
Regimen 1 involved 800 g misoprostol vaginally as a loading dose, followed by 200 g orally every
2 h, starting 3 h after the vaginal dose up to a maximum of 1400 g; regimen 2 involved 400 g
misoprostol orally every 4 h up to a maximum of 1200 g.
c
Multiple complications were possible.

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